STAT+: Will controversy over new Alzheimer’s drug spell the end for the FDA’s faster approval process?
WASHINGTON — For most of its history, the Food and Drug Administration’s shortcut pathway for approving certain medicines was hardly contentious among anyone but the most diehard agency nerds; for years, only a handful of drug makers even used it.
Now, however, just as the accelerated approval program is reaching peak popularity, key supporters, including Oncology Center of Excellence Director Rick Pazdur, are warning that it’s “under attack.”
